Data Integrity and Quality Issues Found at China Facility

FDA sent a warning letter to Shandong Vianor Biotech Co., Ltd. that claimed the company failed to follow proper data integrity and quality control procedures.

Sep 28, 2017

By BioPharm International Editors

FDA sent a warning letter, dated Sept. 12, 2017, to Shandong Vianor Biotech Co., Ltd. after an inspection of the company’s Linyi Shandong, China facility showed a lack of data integrity, quality control, and equipment maintenance. The FDA inspection was conducted from May 8–10, 2017.

The warning letter stated that the company falsified analytical test results to support release of product into the United States. A certificate of analysis (CoA) reported passing results for a laboratory analysis that actually showed a product lot was subpotent. “When questioned about why the CoA reported passing results even though the batch actually failed, your quality unit manager stated, ‘I made a mistake,’” the agency stated in the letter.

The company also tried to impede the agency’s investigation. Investigators were barred from accessing a laboratory room. When the investigators were eventually allowed into the room, they found no equipment and were then told the actual laboratory was located offsite. Investigators were not given access to this offsite laboratory. “When an owner, operator, or agent delays, denies, limits, or refuses an inspection, the drugs manufactured, processed, packed, or held in the facility may be deemed adulterated under section 501(j) of the [Food Drug and Cosmetic Act],” the agency stated.

Investigators also found unmaintained equipment in the facility, including equipment with rusted and corroded screws.

FDA placed the company on Import Alert 66-40 on August 22, 2017 and stated in the warning letter that, if the company did not correct the violations, the agency may refuse admission of products manufactured at that facility into the United States.